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Bupropion hydrobromide - Generic Drug Details

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Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-nine patent family members in seventeen countries.

There are thirty-six drug master file entries for bupropion hydrobromide. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: bupropion hydrobromide

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list36
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: bupropion hydrobromide

Tentative approvals for BUPROPION HYDROBROMIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL174MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL522MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYes7,649,019► subscribeY ► subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYes7,569,610► subscribe ► subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXNo7,569,610► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: bupropion hydrobromide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,932,628Modified release formulations of a bupropion salt► subscribe
7,579,380Modified release formulations of a bupropion salt► subscribe
7,563,823Modified release formulations of a bupropion salt► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bupropion hydrobromide

Country Document Number Estimated Expiration
EcuadorSP077999► subscribe
Japan2011500865► subscribe
Israel185760► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BUPROPION HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/019United Kingdom► subscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
/2000Austria► subscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018Denmark► subscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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